Providing Treatment Information for Prostate Cancer Patients after Biopsy and Surgery

The Decipher Biopsy and Decipher Post-Op tests help you and your doctor decide next steps in your prostate cancer care.

Contact the GenomeDx Customer Support Team 1.888.792.1601 (toll-free) [email protected]

Know your prostate cancer risk The Decipher Biopsy test is the most accurate way to determine the aggressiveness of your prostate cancer and assess your personal risk of metastasis. Using advanced whole genome technology, Decipher Biopsy provides valuable information to you and your doctor so that you can make more informed decisions about your next steps in managing your prostate cancer.

• Is active surveillance through PSA monitoring sufficient for me?

• Is localized treatment sufficient? • Do I need more than one therapy (multi-modal therapy)?

Decipher Classification

Patient Management Recommendations

Decipher Biopsy Low Risk

Favorable prognosis – may be suitable for active surveillance and may have excellent outcomes with local therapy alone1-3

Decipher Biopsy High Risk

Unfavorable prognosis – may not be suitable for active surveillance and may benefit from intensification with multi-modal therapy1-3

References: 1. Klein, E.A., et al., Decipher Genomic Classifier Measured on Prostate Biopsy Predicts Metastasis Risk. Urology, 2016; DOI: http://dx.doi.org/10.1016/j.urology.2016.01.012 2. Knudsen, B.S., et al., Application of a Clinical Whole-Transcriptome Assay for Staging and Prognosis of Prostate Cancer Diagnosed in Needle Core Biopsy Specimens. Journal of Molecular Diagnostics, 2016; In Press. 3. Lee, Hak J., et al., “Evaluation of a Genomic Classifier in Primary Tumor and Lymph Node Metastases in Pre- and Post-Radical Prostatectomy Tissue Specimens from Patients with Lymph Node Positive Prostate Cancer” presented at the 2015 annual meeting of the American Society of Clinical Oncology.

Answer the following questions to determine if Decipher® Biopsy is right for you: Y N Have you had a prostate biopsy positive for cancer? . . . ¡ ¡ Did your doctor indicate that any of the following apply to you after biopsy? Very Low Risk • Prostate Cancer Stage T1c tumor, AND biopsy Gleason score of 6 or less, AND PSA level less than 10ng/mL, AND presence of disease in fewer than 3 biopsy cores, AND less than 50% prostate cancer involvement in any core, AND PSA density less than 0.15 ng/mL/g. . . . . . . . . . . . ¡

¡

Low Risk • Prostate Cancer Stage T1a, T1b, T1c, or T2a tumor, AND PSA level less than 10ng/mL, AND biopsy Gleason score of 6 or less . . . . . . . . . . . . . ¡

¡

Intermediate Risk • T2b or T2c tumor, OR PSA level between 10-20ng/mL, OR biopsy Gleason score of 7 . . . . . . . . . . . . . . . . . . ¡

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High Risk • T3a tumor, OR PSA level greater than 20ng/mL, OR biopsy Gleason score between 8 and 10 . . . . . . . . . . ¡

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If you answered yes to any of the questions, then the Decipher Biopsy test may play a role in determining what type of therapy you may need. Contact your doctor to find out how Decipher might play a role in your treatment planning or contact the GenomeDx Customer Support Team at 1.888.792.1601 (toll-free) or e-mail [email protected].

Not all prostate cancers are alike The Decipher test: • Tells  you how likely your cancer is to spread (or metastasize)

beyond your prostate • Categorizes  most patients into Decipher high or low risk, to help

determine what to do after your prostate has been removed (radical prostatectomy)

Decipher Test Result

Treatment After Your Prostate Cancer Surgery

Treatment for detectable PSA rise (Biochemical Recurrence)

High Risk

May benefit from early radiation1,2

May require intensification of therapy beyond radiation3

Low Risk

May be safely managed with observation until PSA rise (if any)1,2

Excellent prognosis with SRT and may avoid concurrent hormone therapy3

References 1. Den, R.B., et al., A genomic classifier identifies men with adverse pathology after radical prostatectomy who benefit from adjuvant radiation therapy. J of Clin Oncol 2015; 33:944-951. 2. Den, R. et al., A Genomic Prostate Cancer Classifier predicts Biochemical Failure and Metastasis in Patients Following Post Operative Radiation Therapy. Int J Radiat Oncol Biol Phys., 2014 Aug 1; 89(5): 1038-46. 3. Freedland, S.J., et al., Utilization of a genomic classifier for prediction of metastasis following salvage radiation therapy after radical prostatectomy. European Urology. 2016; DOI: 10.1016/j.eururo.2016.01.008.

Answer the following questions to determine if Decipher® is right for you:

Have you had a radical prostatectomy (prostate removed)

Y

N

to treat your prostate cancer? . . . . . . . . . . . . . . . . . . ¡ ¡ Did your doctor indicate that any of the following applied to you after surgery? Medicare Indications • Positive surgical margins . . . . . . . . . . . . . . . . . . . . ¡ ¡ • Extraprostatic extension . . . . . . . . . . . . . . . . . . . . ¡ ¡ • Seminal Vesicle Invasion . . . . . . . . . . . . . . . . . . . . ¡ ¡ • Bladder Neck Invasion . . . . . . . . . . . . . . . . . . . . . ¡ ¡ • Has your PSA started to rise after surgery? . . . . . . . . . ¡ ¡ Additional Indications • Was your pre-surgery PSA 20ng/mL or higher? . . . . . . . ¡ ¡ • High Gleason Score (≥7) . . . . . . . . . . . . . . . . . . . . . ¡ ¡ • Tertiary Gleason 5 . . . . . . . . . . . . . . . . . . . . . . . . ¡ ¡ • Perineural or Lymphovascular Invasion . . . . . . . . . . . . ¡ ¡ • Lymph node involvement . . . . . . . . . . . . . . . . . . . . ¡ ¡

If you answered yes to any of the above questions, then Decipher may play a role in determining if and when you need additional therapy after surgery. If you have at least one of the Medicare indications, you will have no out-of-pocket cost.

This test is covered by Medicare. We accept all private insurance plans and have a generous financial aid program for qualified patients. Contact your doctor to find out how Decipher might play a role in your postoperative treatment planning or contact the GenomeDx Customer Support Team at 1.888.792.1601 (toll-free) or e-mail [email protected].

General Overview Decipher High Risk

Ra B Th

Decipher Low Risk

Ob

Order Decipher

Radical Prostatectomy

PSA Rise/ Biochemical Recurrence

Order De

Please discuss further details with your doctor.

*Salvage radiation therapy (SRT)

Radiation (ART Better Results han SRT)

bservation

ecipher

PSA Rise/BCR

Decipher High Risk

May require intensification of therapy beyond radiation

Decipher Low Risk

Excellent prognosis with SRT* and may avoid concurrent hormone therapy

Excellent prognosis with SRT* and may avoid concurrent hormone therapy

What is the Decipher Test? Based on the patient’s personal tumor-based genomics, Decipher Prostate Cancer Classifier: Decipher Biopsy • Performed on your prostate biopsies diagnosed as positive for cancer • May help determine which men may be suitable candidates for active surveillance, which may need local therapy, and which men may need intensified therapy

Decipher Post-Op • Performed on your prostate after surgery (after it has been removed) • May help determine which men after prostate surgery can be safely monitored and which men need additional treatment Access for All Patients

• Medicare Coverage (Mol Dx LCD ID L35868): Decipher Post-Op test covered for Medicare beneficiaries

• Private Insurance Coverage • Proven and comprehensive financial assistance for patients

To learn more about Decipher, contact the GenomeDx Customer Support Team at 1.888.792.1601 (toll free) or email at [email protected].

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